MDCG New Technologies WG – interplay between MDR/IVDR and the 1
EU Artificial Intelligence Act (AIA) 2
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This document aims to reflect questions raised during the New Technologies WG workshop on
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ABHS N 764
SNAPSHOT
Medical Devices – List of European Standards intended to be cited
in the Official Journal of the European Union (OJEU) under the
Directives:
• on Medical De
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Medical Device
Medical Device Coordination Group Document MDCG 2024-XX
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2
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MDCG 2024-XX 6
Guidance on the legal status of 7
medical device sof
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JICF survey on the HERA Stakeholders' HUB
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The project is initiated in response to the “Communication on addressing medicine shortages in the EU” (Ref. COM(2023)
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Template for comments
Project: CIE WP 22
Document: draft MDCG clinical evaluation
Date: 26 July 2024
Page 1(1)
NCA1 CIE / DA NBOG/ COM / Other
Line number / reference
Type of comment2
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Medical Device
Medical Device Coordination Group Document MDCG 2019-9 Rev.21
MDCG 2019-9 Rev.21
Summary of safety and clinical performance
A guide for manufacturers and
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1
ENQUIRY TO
MEDICAL DEVICE COMPETENT AUTHORITIES
Helsinki procedure 2021
Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR)
Confidential between Member States
Prob
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Medical Devices
Medical Device Coordination Group Document MDCG 2024-1-3
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MDCG 2024-1-3
Guidance on the vigilance system
for CE-marked dev
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Medical Devices
Medical Device Coordination Group Document MDCG 2024-1-2
MDCG 2024-1-2
Guidance on the vigilance system
for CE-marked devices
DSV
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Medical Devices
Medical Device Coordination Group Document MDCG 2024-1-4
MDCG 2024-1-4
Guidance on the vigilance system
for CE-marked devices
DSVG
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